Medical Device Quality Inspector — 1st Shift, Growth

Regulatory Jobs; Mayfield (OH); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Overtime available

Job summary

Regulatory Jobs is seeking a detail-oriented Product Quality Inspector to ensure the highest standards across incoming materials, in-process production, and finished medical devices. You will perform inspections, functional testing, and evaluations using measurement techniques, and document results in line with GDP.

Essential duties include inspecting parts and assemblies to defined criteria, drafting or revising inspection documents, reviewing device history records for GDP compliance, and

Qualifications

• High school diploma or GED required or equivalent experience.
• Minimum of one year experience performing electrical or mechanical QC/QA inspections.
• Prefer associate’s degree in a technical discipline.
• IPC 610 certification and PCB inspection experience preferred.
• Experience with ISO and FDA audits preferred.
• Experience inspecting QC/QA medical devices, MRI preferred.

Responsibilities

• Perform inspections of purchased parts, subassemblies, in-process product and finished products using standard measurements.
• Document inspection results with quantitative measurements and observations.
• Draft or revise inspection documents based on feedback and best practices.
• Collaborate with Operations and Quality Management to improve inspection methods.
• Review device history records (DHRs) for GDP compliance.
• Write non-conformance reports and ensure timely closure.
• Participate in quality audits of the QMS.
• Other tasks as assigned by management.

Skills

Attention to detail

Self-motivated

Continuous improvement

Multitasking

Interpersonal skills

PC/ERP tools

GDP compliance

Education

High school diploma or GED

Associate’s degree (technical)

Tools

PCBA inspection

IPC 610 certification

ISO/FDA audits

Medical device QC inspection/MRI

Job description

Regulatory Jobs is seeking a detail-oriented Product Quality Inspector to ensure the highest standards across incoming materials, in-process production, and finished medical devices. You will perform inspections, functional testing, and evaluations using measurement techniques, and document results in line with GDP.

Essential duties include inspecting parts and assemblies to defined criteria, drafting or revising inspection documents, reviewing device history records for GDP compliance, and